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NCT03733912 Clinical Trial

Plasticizers and in Vitro Fertilization Outcomes

Fertilization in Vitro Clinical Trial

Official title:
To Investigate the Effect of Plasticizers on the Pregnancy in Vitro Fertilization Cycles

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03733912
Other study ID # VGHKS18-CT3-09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 11, 2018
Est. completion date December 31, 2020

Study information
Verified date February 2021
Source Kaohsiung Veterans General Hospital.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes

Description:

This study was conducted in a medical center in southern Taiwan. 80 infertile female patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in the infertility outpatient were enrolled in this study. The participates were divided into two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF cycle (n = 40). After getting the consent of the patients, we plan to do a questionnaire survey. Additionally, environmental dust and urine were sampled and analyzed the concentration of plasticizers metabolites.The aim of this study is to investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 40 Years
Eligibility Inclusion Criteria: - Infertile women undergoing in vitro fertilization cycles - Normal ovarian reserve (AMH > 1.0 and AFC ? 5) Exclusion Criteria: - Daily homestay time > 12 hrs - Diminished ovarian reserve (AMH ? 1.0 or AFC<5) - Oophorectomy - Gynecologic cancer patients - Severe male infertility

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Phthalate metabolites measurement
To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups

Locations
Country Name City State
Taiwan Kaohsiung Veterans General Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

Becker K, Seiwert M, Angerer J, Heger W, Koch HM, Nagorka R, Rosskamp E, Schlüter C, Seifert B, Ullrich D. DEHP metabolites in urine of children and DEHP in house dust. Int J Hyg Environ Health. 2004 Oct;207(5):409-17. — View Citation

Chen ML, Chen JS, Tang CL, Mao IF. The internal exposure of Taiwanese to phthalate--an evidence of intensive use of plastic materials. Environ Int. 2008 Jan;34(1):79-85. Epub 2007 Aug 31. — View Citation

Du YY, Guo N, Wang YX, Hua X, Deng TR, Teng XM, Yao YC, Li YF. Urinary phthalate metabolites in relation to serum anti-Müllerian hormone and inhibin B levels among women from a fertility center: a retrospective analysis. Reprod Health. 2018 Feb 23;15(1):33. doi: 10.1186/s12978-018-0469-8. — View Citation

Hauser R, Gaskins AJ, Souter I, Smith KW, Dodge LE, Ehrlich S, Meeker JD, Calafat AM, Williams PL; EARTH Study Team. Urinary Phthalate Metabolite Concentrations and Reproductive Outcomes among Women Undergoing in Vitro Fertilization: Results from the EART — View Citation

Jurewicz J, Hanke W. Exposure to phthalates: reproductive outcome and children health. A review of epidemiological studies. Int J Occup Med Environ Health. 2011 Jun;24(2):115-41. doi: 10.2478/s13382-011-0022-2. Epub 2011 May 19. Review. — View Citation

Koch HM, Lorber M, Christensen KL, Pälmke C, Koslitz S, Brüning T. Identifying sources of phthalate exposure with human biomonitoring: results of a 48h fasting study with urine collection and personal activity patterns. Int J Hyg Environ Health. 2013 Nov;216(6):672-81. doi: 10.1016/j.ijheh.2012.12.002. Epub 2013 Jan 18. — View Citation

Messerlian C, Souter I, Gaskins AJ, Williams PL, Ford JB, Chiu YH, Calafat AM, Hauser R; Earth Study Team. Urinary phthalate metabolites and ovarian reserve among women seeking infertility care. Hum Reprod. 2016 Jan;31(1):75-83. doi: 10.1093/humrep/dev292. Epub 2015 Nov 15. — View Citation

Mínguez-Alarcón L, Gaskins AJ. Female exposure to endocrine disrupting chemicals and fecundity: a review. Curr Opin Obstet Gynecol. 2017 Aug;29(4):202-211. doi: 10.1097/GCO.0000000000000373. Review. — View Citation

Richardson MC, Guo M, Fauser BC, Macklon NS. Environmental and developmental origins of ovarian reserve. Hum Reprod Update. 2014 May-Jun;20(3):353-69. doi: 10.1093/humupd/dmt057. Epub 2013 Nov 27. Review. — View Citation

Shea KM; American Academy of Pediatrics Committee on Environmental Health. Pediatric exposure and potential toxicity of phthalate plasticizers. Pediatrics. 2003 Jun;111(6 Pt 1):1467-74. Review. — View Citation

Vabre P, Gatimel N, Moreau J, Gayrard V, Picard-Hagen N, Parinaud J, Leandri RD. Environmental pollutants, a possible etiology for premature ovarian insufficiency: a narrative review of animal and human data. Environ Health. 2017 Apr 7;16(1):37. doi: 10.1186/s12940-017-0242-4. Review. — View Citation

Wu H, Ashcraft L, Whitcomb BW, Rahil T, Tougias E, Sites CK, Pilsner JR. Parental contributions to early embryo development: influences of urinary phthalate and phthalate alternatives among couples undergoing IVF treatment. Hum Reprod. 2017 Jan;32(1):65-75. Epub 2016 Dec 7. — View Citation

Wu H, Olmsted A, Cantonwine DE, Shahsavari S, Rahil T, Sites C, Pilsner JR. Urinary phthalate and phthalate alternative metabolites and isoprostane among couples undergoing fertility treatment. Environ Res. 2017 Feb;153:1-7. doi: 10.1016/j.envres.2016.11. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Phthalate of urine Phthalate metabolites concentrations through study completion, an average of 1 year
Secondary Phthalate of environmental dust Phthalate metabolites concentrations through study completion, an average of 1 year
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